A Phase 3, Open-Label, Multicenter, Randomized Study to evaluate the Efficacy and Safety of Romosozumab Compared with Bisphophonates in Children and Adolecents with Osteogenesis Imperfecta

Conditions

Osteogenesis Imperfecta

Brief summary

Number of clinical fractures (clinical vertebral fractures and nonvertebral) through Month 12, Number of any fractures (new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral) through Month 12, Change from baseline in lumbar spine BMD Z-score at Month 12, as assessed by DXA

Detailed description

Change from baseline in lumbar spine BMD Z score at Month 12 (this is not a secondary endpoint for the EMA as it is already listed as one of the primary endpoints), Change from baseline in total hip BMD Z score at Month 12, as assessed by DXA, Change from baseline in femoral neck BMD Z score at Month 12, as assessed by DXA, •Subject incidence of nonvertebral fractures through month 12 •Subject incidence of long bone fractures through month 12 •Number of new or worsening vertebral fractures through Month 12 •Number of nonvertebral fractures through Month 12 •Number of long bone fractures through Month 12, Change from baseline in CHQ-PF-50 Physical Summary score, CHAQ-CV disability score and Wong-Baker Faces Pain Rating, Serum concentration of romosozumab at Day 1, Month 6, and Month 12

Related papers

No related papers found yet.

Interventions

DRUGCALCIUM

DRUGEVENITY 105 mg solution for injection in pre-filled syringe

DRUGERGOCALCIFEROL

DRUG-

DRUGEVENITY 105 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Number of clinical fractures (clinical vertebral fractures and nonvertebral) through Month 12, Number of any fractures (new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral) through Month 12, Change from baseline in lumbar spine BMD Z-score at Month 12, as assessed by DXA	—

Secondary

Measure	Time frame
Change from baseline in lumbar spine BMD Z score at Month 12 (this is not a secondary endpoint for the EMA as it is already listed as one of the primary endpoints), Change from baseline in total hip BMD Z score at Month 12, as assessed by DXA, Change from baseline in femoral neck BMD Z score at Month 12, as assessed by DXA, •Subject incidence of nonvertebral fractures through month 12 •Subject incidence of long bone fractures through month 12 •Number of new or worsening vertebral fractures through Month 12 •Number of nonvertebral fractures through Month 12 •Number of long bone fractures through Month 12, Change from baseline in CHQ-PF-50 Physical Summary score, CHAQ-CV disability score and Wong-Baker Faces Pain Rating, Serum concentration of romosozumab at Day 1, Month 6, and Month 12	—

Measure

Time frame

Change from baseline in lumbar spine BMD Z score at Month 12 (this is not a secondary endpoint for the EMA as it is already listed as one of the primary endpoints), Change from baseline in total hip BMD Z score at Month 12, as assessed by DXA, Change from baseline in femoral neck BMD Z score at Month 12, as assessed by DXA, •Subject incidence of nonvertebral fractures through month 12 •Subject incidence of long bone fractures through month 12 •Number of new or worsening vertebral fractures through Month 12 •Number of nonvertebral fractures through Month 12 •Number of long bone fractures through Month 12, Change from baseline in CHQ-PF-50 Physical Summary score, CHAQ-CV disability score and Wong-Baker Faces Pain Rating, Serum concentration of romosozumab at Day 1, Month 6, and Month 12

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Countries

Austria, Belgium, France, Germany, Hungary, Italy, Poland, Slovakia, Spain

Outcome results

None listed